AAMI News, September 2020, Vol.55, No.9

Issue Highlights

• FDA Issues Second EUA for Heart Pump
• A Full Slate of HTM Learning Events this Fall
• Behind the Scenes at the FDA: MRI Safety Guidance
• Just Published! AAMI HTM Succession Guide
• Pediatric Device Competition Highlights COVID-19 Innovations
• FDA Increases User Fees for 2021
• In Memoriam: Zachary Collins
• COVID-19 Medical Device Shortage List Posted by FDA

Focus on Risk Management

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• Impossible Mission Delivers Ventilator Test Systems for ‘Project V’
  Last spring, manufacturers rallied to mass produce the critical care ventilators needed to treat patients with COVID- 19. But every ventilator must also be tested and validated before it is shipped—and testing equipment is unique to each brand of ventilator and must be custom-built.
• New HTM Certification Focuses on Next-Gen Workforce
  It’s no secret that the HTM field is expecting a glut of open positions. The U.S. Bureau of Labor Statistics projects that 2,000 new medical equipment repairer positions will be created by 2028, while clinical lab and industry technician positions are facing even more substantial growth. However, what’s worrying managers is that an estimated 50% of the current clinical engineering workforce is over the age of 50. 
• FDA Issues Second EUA for Heart Pump during COVID-19
  The Food and Drug Administration (FDA) has issued a second Emergency Use Authorization (EUA) for a heart pump for the support of patients with COVID-19. The new EUA is for the leftsided Impella heart pump made by Abiomed of Danvers, MA.
• News in Brief: September 2020
• Focus on Risk Management: Experts Weigh In on Today’s Top Risk Management Issues
  In a recent Biomedical Instrumentation and Technology (BI&T) article, AAMI convened a roundtable of risk management experts to discuss progress, challenges, and trends in the field:
• Focus on Risk Management: Update on Risk Management Standards
  Ensuring that a device is sufficiently safe requires not only premarket testing and evaluation, but also careful consideration of how that device might fail or be misused in a way that could lessen its effectiveness or harm a patient.
• AAMI Consensus Reports Guide ‘Bubble Helmet’ Development as COVID-19 Response
  As the COVID-19 pandemic continues to afflict the world, innovative medical device designs are receiving emergency use authorizations from the Food and Drug Administration (FDA), including for production of ventilatory assistance helmets (VAHs). Now, AAMI has released two consensus reports (CRs) to guide manufacturers in making safe and reliable VAHs.
• FDA Makes Progress on Safety and Performance Pathway
  As part of its efforts to modernize the 510(k) program, the Food and Drug Administration (FDA) unveiled its Safety and Performance Based Pathway in 2018 as a 510(k) premarket clearance route that would allow submitters to demonstrate safety and effectiveness using FDA-identified performance criteria. The FDA predicted operationalization of the pathway once device types and performance criteria performance were identified.
• FDA Makes Catalog of Regulatory Science Tools Publicly Available
  The Food and Drug Administration (FDA) has posted on its website a variety of regulatory science tools developed by its R&D arm, the Office of Science and Engineering Laboratories (OSEL) at the Center for Devices and Radiological Health.
• Behind the Scenes at the FDA: MRI Safety Guidance
• Just Published! AAMI HTM Succession Planning Guide
  For healthcare technology management (HTM) leaders who direct or manage programs and people, sudden employee resignations and even planned retirements can disrupt operations.
• Pediatric Device Competition Highlights COVID-19 Innovations
  The National Capital Consortium for Pediatric Device Innovation (NCC-PDI), based in Washington, DC, recently announced eight winners in a special pediatric device competition focused on treating COVID-19.
• AAMI Forges Partnership to Bring Industry Training to Costa Rica
  AAMI has joined forces with the Costa Rican Investment Promotion Agency (CINDE) to bring AAMI education to the country’s professional training and device manufacturing campuses.
• FDA Increases User Fees for 2021
  The Food and Drug Administration (FDA) has announced increases for its medical device user fees for fiscal year 2021. The average increase in fees is 7%, greater than last year’s 6% increase but tempered by decreases in agency personnel costs.
• Career Center: AAMI Foundation Scholarship Winners: Up-and-Comers in HTM Careers
• One on One: Ed Margerrison
  Ed Margerrison PhD, is the director of the Office of Science and Engineering Laboratories (OSEL) at the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). Margerrison was elected to the AAMI Board of Directors this year.
• Member News: September 2020
• In Memoriam: Zachary Collins
• Standards Spotlight: AAMI Standards Department Restructured to Meet Dynamic Needs
  Amanda Benedict, AAMI’s vice president of standards, explains the recent restructuring of the standards department to meet current and projected needs.
• COVID-19 Medical Device Shortage List Posted by FDA
  Since the COVID-19 pandemic began, nurses, doctors, hospital leaders, and public health officials have expressed alarm about medical device shortages. Last month, the Food and Drug Administration (FDA) posted a list of specific categories of medical devices determined by the agency to be in shortage during the COVID-19 public health emergency.